MPI Predicts Outcome of CRC Elderly Patients (MPI=MULTIDI... | NCT04594655

Studies
MPI Predicts Outcome of CRC Elderly Patients (MPI=MULTIDIMENSIONAL PROGNOSTIC INDEX; CRC=COLORECTAL CANCER)

NCT04594655

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Status

Completed

Last Update Posted

Oct 20, 2020Actual

Enrollment

104Actual

Phase

Not provided

Conditions

Colorectal Cancer
Fragility
Elderly

Interventions

surgery

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Aug 31, 2019Actual

Completion Date

Sep 30, 2019Actual

First Submitted Date

Oct 11, 2020

First Submission Date that Met QC Criteria

Oct 17, 2020

First Posted Date

Oct 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2020

Last Update Posted Date

Oct 20, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giacomo Pata, Principal Investigator, Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaPrincipal Investigator

Lead Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients aged ≥75 year scheduled for CRC surgery were studied (104 cases) and variables associated with major postoperative complications / mortality were evaluated. The importance of this report is that MPI-score resulted strongly associated with major complications and it was a primary component of an individual prediction model.

Detailed Description

Patients aged ≥75 year scheduled for CRC surgery were studied (104 cases) and variables associated with major postoperative complications / mortality were evaluated. The MPI (multidimensional prognostic index)-score resulted strongly associated with major complications. also, it was a primary component of an individual prediction model (LASSO model).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Name	Type	Description	Arm Group Labels	Other Names
surgery	Procedure	colectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MPI and major morbidity	The primary goal of the FRAGIS (Frailty Assessment by Geriatric Investigation in Surgery) study was to evaluate the association between the MPI score and the occurrence of major postoperative complications within 30 days of CRC surgery.	30 days

Secondary Outcomes

Measure	Description	Time Frame
Prediction of complication	The secondary goal was to develop a model to predict the individual risk of postoperative complications, allowing the appropriate patient selection for surgery.	90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All CRC patients aged ≥75 years, who were scheduled for elective surgery and able to express their consent to treatment, were considered.

Exclusion Criteria: emergency surgery; patients aged <75 years; patients unable to sign informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

CRC patients aged ≥75 years

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Uberto Fumagalli, MD	Asst Degli Spedali Civili Di Brescia	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ASST Spedali Civili		Brescia	Lombardy	25100	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided